Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID b174e57c-4e4f-4842-b8f2-f1b067764a68
Route
ORAL
Published
Effective Date 2023-07-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5.4 mg)
Inactive Ingredients
Corn Syrup Eucalyptol Lecithin, Soybean Fd&c Red No. 40 Fd&c Blue No. 1 Acacia Maltodextrin Sucrose

Identifiers & Packaging

Pill Appearance
Shape: oval Color: blue Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-05

Description

 Menthol 5.4 mg

Purpose

Cough Suppressant / Oral anesthetic


Medication Information

Purpose

Cough Suppressant / Oral anesthetic

Description

 Menthol 5.4 mg

Use

Temporarily relieves:

  • cough as may occur with a cold 
  • occasional minor irritation and sore throat
Warning

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. if sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.

Ask a doctor before use if you have :

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanined by excessive phlegm (mucus)

stop use and ask doctor if 

  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • sore throat is severe, or irritation, pain or redness lasts or worsens
  • sore mouth does not improve in 7 days

If pregnant or breast-feeding, ask a health professional before use.

Directions

Adults and children 5 years and over

dissolve 1 lozenges slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor

children under 5 years , ask a doctor 

Product Label

Active Ingredient

 Menthol 5.4 mg

Other Information
  • 11 calories per drop 
  • do not use if bag is torn or open 
  • Contains : Soy
Inactive Ingredients

Corn Syrup, eucalyptus oil, FD&C blue no. 1, FD&C red no.40, gum Arabic, maltodextrin, natural flavor, soy lecithin, sucrose and water

Keep Out of Reach of Children


Structured Label Content

Use

Temporarily relieves:

  • cough as may occur with a cold 
  • occasional minor irritation and sore throat
Purpose

Cough Suppressant / Oral anesthetic

Warning

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. if sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.

Ask a doctor before use if you have :

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanined by excessive phlegm (mucus)

stop use and ask doctor if 

  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • sore throat is severe, or irritation, pain or redness lasts or worsens
  • sore mouth does not improve in 7 days

If pregnant or breast-feeding, ask a health professional before use.

Directions

Adults and children 5 years and over

dissolve 1 lozenges slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor

children under 5 years , ask a doctor 

Product Label (Product label)

Active Ingredient (Active ingredient)

 Menthol 5.4 mg

Other Information (Other information)
  • 11 calories per drop 
  • do not use if bag is torn or open 
  • Contains : Soy
Inactive Ingredients (Inactive ingredients)

Corn Syrup, eucalyptus oil, FD&C blue no. 1, FD&C red no.40, gum Arabic, maltodextrin, natural flavor, soy lecithin, sucrose and water

Keep Out of Reach of Children (Keep out of reach of children)


Advanced Ingredient Data


Raw Label Data

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